Sandoz Receives EC Approval for First Biosimilar for MS
The Biosimilar Tyruko® has been approved for all indications of reference medicine, as the first and only biosimilar to treat relapsing forms of multiple sclerosis (MS) in Europe.
Sandoz, a prominent player in the worldwide generic and biosimilar pharmaceutical industry, has announced that the European Commission (EC) has officially approved the marketing of the inaugural and exclusive biosimilar, Tyruko® (natalizumab), developed by Polpharma Biologics.
About Tyruko® (natalizumab)
Tyruko® has been developed to closely match the reference medicine, a well-established and highly effective anti-α4 integrin monoclonal antibody used as a disease-modifying treatment for relapsing forms of multiple sclerosis (MS). Tyruko is indicated in the EU as a single disease-modifying therapy (DMT) for adults with highly active relapsing-remitting multiple sclerosis (RRMS).
This authorization encompasses its usage as the sole disease-modifying therapy (DMT) for adults who are experiencing highly active RRMS, which is the identical indication as that given to the reference medication Tysabri® (natalizumab) by the EC. Tysabri® is a registered trademark of Biogen MA, Inc.
Rebecca Guntern, President Europe, Sandoz, said:
“Multiple sclerosis is a chronic condition with no cure at present and timely access to affordable, high-quality healthcare is therefore even more essential. Today’s approval brings us one step closer to reducing the burden of this disease for those living with multiple sclerosis in Europe by making the life-enhancing treatments they need more accessible.”
About Multiple Sclerosis (MS)
Multiple sclerosis (MS) is a persistent condition characterized by inflammation and neurodegeneration in the central nervous system, which can significantly impact daily life. The majority of individuals with MS undergo episodes of either new symptoms emerging or a worsening of existing ones, termed relapses, interspersed with phases of disease remission where symptoms partially or fully ameliorate. Commencing treatment with disease-modifying therapies (DMTs) at an early stage can alter the trajectory of an individual’s MS and diminish the potential for future disability.
In 2019, Sandoz entered a global commercialization agreement with Polpharma Biologics for the biosimilar natalizumab. As per the terms of this agreement, Polpharma Biologics will retain responsibilities for the medicine’s development, manufacturing, and drug substance supply. Sandoz, through an exclusive global license, has the rights to market and distribute this biosimilar in all markets.
The comprehensive regulatory submission package included evidence derived from extensive analytical and functional characterization, as well as results from a Phase I PK/PD study and a confirming Phase III Antelope study involving patients with RRMS. Both studies successfully met their primary endpoints, confirming that the biosimilar closely matches the reference biologic in terms of pharmacokinetics, efficacy, safety, and immunogenicity. Tyruko® is available in the same strength and dosage form, administered intravenously (IV), with the same dosing regimen and presentation as the reference medicine.
About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Their aim is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. With an ambition to be the world’s leading and most valued generics company, its broad portfolio of high-quality medicines covers all major therapeutic areas.
Sandoz is dedicated to facilitating access to critical and potentially life-changing biologic medicines for millions of patients in a sustainable and affordable manner across various therapeutic areas, including immunology, oncology, supportive care, and endocrinology. With eight biosimilars already in the market and an additional 25 assets in various stages of development, Sandoz maintains a leading global portfolio. Since introducing the first biosimilar in Europe in 2006, Sandoz has played a pivotal role in providing early and expanded patient access to transformative medicines, while also generating healthcare cost savings and fostering competition that drives further innovation.
For more information please visit: www.sandoz.com
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